Trial of Small Intestine Submucosa (SIS) Mesh for Anterior Repair: A Pilot Study (Anterior SIS)

University of Calgary

Status and phase: Completed; Phase 3

Conditions: Anterior Pelvic Organ Prolapse

Treatments: Procedure: Anterior prolapse repair; Device: SIS mesh (Cook Medical)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00955448

Ethics: E-22217

Anterior SIS 300609

Details and patient eligibility

About

Prolapse occurs when pelvic organs drop down and cause a bulging of the tissues. An "anterior wall prolapse" occurs when the front of the vagina loses its support, and the bladder drops down and rotates into the vaginal opening. The bladder can cause a bulge out of the vagina.

One of the treatment options available is to repair the anterior wall surgically. The goals of surgery are to return the anatomy to its usual position, ensuring that all the pelvic floor organs (bladder, vagina and rectum) can function properly. The ideal surgical repair would also be long lasting.

Two surgical options are routinely performed in Calgary for repair of an anterior compartment prolapse. One option involves fixing the organs back in place using sutures. The other option uses sutures plus a mesh made of small intestine submucosa (SIS) that is already licensed for use in Canada. The SIS mesh is slowly absorbed after it is placed in the pelvic area. The investigators do not know which of these two options is the best surgical procedure. Both may have different advantages that would result in better results. This study is designed to try and find out if one of these procedures is better, and if a larger study may be needed.

Enrollment: 57 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women who require surgical correction for anterior compartment prolapse. (Concomitant surgery is permitted.)
• Point Ba of 0 or greater: that is a positive Ba, indicating that the prolapse is beyond the introitus, not within the vagina.
• Patient must consent to participate in the study.

Exclusion criteria

• Having an obliterative procedure (Lefort procedure or colpocleisis).
• Allergy to graft material.
• Immunocompromised.
• Previous anterior compartment repair.
• Are unable to understand English.
• Will be unavailable for follow-up.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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57 participants in 2 patient groups

SIS Mesh (Cook Medical)

Experimental group

Description:

Anterior prolapse repair will be reinforced using SIS mesh

Treatment:

Device: SIS mesh (Cook Medical)

Procedure: Anterior prolapse repair

No-mesh

Active Comparator group

Description:

Anterior prolapse repair with no mesh reinforcement

Treatment:

Procedure: Anterior prolapse repair